A Study of Olaratumab (IMC-3G3) in Previously Treated Participants With Unresectable and/or Metastatic Gastrointestinal Stromal Tumors

NCT ID: NCT01316263

Last Updated: 2017-03-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2012-11-30

Brief Summary

The purpose of this study is to evaluate the tumor response of stable disease (SD), partial response (PR), or complete response (CR) [according to Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST v1.1 criteria)] at 12 weeks in participants with Gastrointestinal Stromal Tumors (GIST) harboring platelet-derived growth factor receptor alpha (PDGFRα) mutations and patients with GIST not harboring PDGFRα mutations.

Conditions

Gastrointestinal Stromal Tumor (GIST)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PDGFRα mutation negative

Participants with GIST with genotypes that do not have a PDGFRα mutation given 20 milligrams per kilogram (mg/kg) Olaratumab intravenously (IV) every 14 days.

Group Type: EXPERIMENTAL

Olaratumab

Intervention Type: BIOLOGICAL

Administered IV

PDGFRα mutation positive

Participants with GIST with genotypes that have a PDGFRα mutation given 20 mg/kg Olaratumab IV every 14 days.

Group Type: EXPERIMENTAL

Olaratumab

Intervention Type: BIOLOGICAL

Administered IV

Interventions

Olaratumab

Administered IV

Intervention Type: BIOLOGICAL

Other Intervention Names

LY3012207; IMC-3G3

Eligibility Criteria

Inclusion Criteria

• Participant has histologically or cytologically confirmed, unresectable and/or metastatic GIST
• Participant has measurable disease
• Participant has documented objective progression following, or intolerance to, treatment with both imatinib and sunitinib
• Participant's Eastern Cooperative Oncology Group (ECOG) performance status (PS) is 0 to 2
• Participant has either:

1. prior results from growth factor receptor associated with tyrosine kinase activity (KIT) and PDGFRα mutation analysis that meet analytical criteria as defined for the on-study analysis of these mutations and tumor tissue (from either primary or metastatic tumor) that can be submitted for analysis within 30 days after the first dose of study therapy; or

2. if prior results from KIT and PDGFRα mutation analysis are not available or do not meet analytical criteria as above, then tumor tissue (from either primary or metastatic tumor) must be submitted for genotype testing at the latest 28 days prior to the first dose of study therapy

• Participant has adequate hematologic, hepatic, renal and coagulation function
• Women of childbearing potential and sexually active males must agree to use adequate contraception prior to study and for at least 12 weeks after the last dose of IMC-3G3
• Participant has a life expectancy of ≥ 3 months

Exclusion Criteria

• Participant has untreated central nervous system metastases, and as a result, is clinically unstable with regard to neurologic function
• Participant has a history of another primary cancer
• Participant has received any investigational therapy within 14 days prior to registration, or is currently enrolled in any other type of medical research
• Participant is receiving concurrent treatment with other anticancer therapy
• Participant has known human immunodeficiency virus (HIV) infection
• Participant has undergone major surgery within 28 days prior to registration
• If female, participant is pregnant or breastfeeding

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

ImClone Investigational Site

Chicago, Illinois, United States

ImClone Investigational Site

Boston, Massachusetts, United States

ImClone Investigational Site

Edegem, , Belgium

ImClone Investigational Site

Leuven, , Belgium

ImClone Investigational Site

Bad Saarow, , Germany

ImClone Investigational Site

Berlin, , Germany

ImClone Investigational Site

Essen, , Germany

ImClone Investigational Site

Mannheim, , Germany

ImClone Investigational Site

Tübingen, , Germany

ImClone Investigational Site

Leiden, , Netherlands

ImClone Investigational Site

Warsaw, , Poland

ImClone Investigational Site

Madrid, , Spain

ImClone Investigational Site

Madrid, , Spain

Countries

United States; Belgium; Germany; Netherlands; Poland; Spain

References

Wagner AJ, Kindler H, Gelderblom H, Schoffski P, Bauer S, Hohenberger P, Kopp HG, Lopez-Martin JA, Peeters M, Reichardt P, Qin A, Nippgen J, Ilaria RL, Rutkowski P. A phase II study of a human anti-PDGFRalpha monoclonal antibody (olaratumab, IMC-3G3) in previously treated patients with metastatic gastrointestinal stromal tumors. Ann Oncol. 2017 Mar 1;28(3):541-546. doi: 10.1093/annonc/mdw659.

Reference Type: DERIVED

PMID: 28426120 (View on PubMed)

Other Identifiers

CP15-1008

Identifier Type: OTHER

Identifier Source: secondary_id

I5B-IE-JGDH

Identifier Type: OTHER

Identifier Source: secondary_id

2010-022560-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

14244

Identifier Type: -

Identifier Source: org_study_id